Diploma in ICH-GCP Managed Trials

Get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials

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3 - 5 Sep 2025

or

10 - 12 Nov 2025

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On location

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Danish

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21,000 DKK ex VAT

(app. 2,823 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this course, you get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course consists of presentations from authorities and experts in clinical trials complemented by group work and cases.

The starting point of this course is current legislation and guidelines and the different roles and responsibilities of monitors and investigators/study nurses.

Furthermore, focus is on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimise your collaboration with your partners.

To achieve a Diploma you must pass the exam, which is held approximately four weeks after the course. The exam must be purchased separately . If you do not take the exam, you will receive a certificate of completion.


This is what course participants say

"It was a very well-planned course with good lectures and course leaders who had a great overview and managed the course very well."

Pernille Videbæk Pedersen, GCP-Coordinator, Aarhus University.


"It was a very well-structured course, which academically had a high level." 

Pernille Skovby, National Coordinator at DanPedMed.


"Good and relevant professional content. Informative to meet with stakeholders from both the clinic, authorities, public and private sectors." 

Sara Jensen, Project Nurse, Sygehus Lillebælt


"Excellent instructors, lovely location, engaged participants and organisers." 

Vibeke Jespersen, Project Nurse, Rigshospitalet


    Keywords

    • Good Clinical Practice ICH-GCP
    • National legislation
    • Audit and inspection
    • Essential documents
    • Safety reporting
    • Site management from site and sponsor’s/CRO’s perspective

    You deserve to be celebrated!

    We are excited every time one of our course participants completes a diploma: You've made a significant investment in yourself, and that deserves recognition. That's why we host a diploma ceremony twice a year. You can find available dates and register here. At the event, you'll receive your diploma, and we'll provide some refreshments. Feel free to bring your family along.

    Should you prefer to receive you diploma via mail, this is, of course, also possible.


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    Course leader & lecturers

    • Lene Palfelt
      Course leader
      Head of People & Capabilities
      Novo Nordisk A/S
    • Lærke Brygger Madsen
      Course leader
      GCP-koordinator, cand.scient.med
      Region Nordjylland
    See all

    Watch the video

    Is this course for you?

    This diploma course is a basic training aimed at new monitors, project nurses, and investigators. It is an advantage to have some experience in the field.

    What you will learn

    1. How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
    2. What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
    3. How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
    4. How to collect, monitor and file clinical trial related data throughout the clinical trial
    5. The importance of timely and accurate management of safety data
    6. The importance of correct handling of study medication from packaging to destruction

    What your company will get

    1. A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
    2. A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
    3. A GCP professional who knows the principles and practical aspects of effective site monitoring
    4. An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
    5. An employee who understands the responsibilities and duties of both investigator and sponsor

    Course calendar

    Choose your starting date
    Starting 3 Sep 2025
    Starting 10 Nov 2025
    Starting 13 Apr 2026
    Starting 24 Aug 2026
    Starting 30 Nov 2026
    3 Sep 2025 9:00-16:30
    Day 1
    • ICH-GCP
      • Investigator’s role and responsibilities
      • Investigator’s oversight/supervision
      • Sponsor’s role and responsibilities
      • Sponsor’s oversight
      • Danish legislation
    • Introduction to clinical drug development
    • Involved authorities:
      • Danish Medicines Agency (DKMA)
        • DKMA’s role
        • Danish legislation on this topic
        • Approval procedure
      • The independent ethical committee system
        • Overview of the committee system
        • Approval process
        • Subject information and informed consent
    • Group work
      4 Sep 2025 8:30-17:00
      Day 2
      • Clinical trial data (collection)
        • Trial data
        • CRF
        • Source data
      • General Data Protection Regulation (GDPR)
        • Terminology
        • Distribution of responsibilities (Data owner / Data processor)
      • Essential documents
        • Trial Master File
        • Investigator’s Brochure
        • Protocol
        • Subject information and informed consent
        • ID- and Screenings Log
        • Delegation log
        • Contracts
      • Safety reporting
        • Definitions
        • Standards for reporting
        • Areas of responsibilities
      • Group work
      • Handling of investigational medicinal product (IMP) in clinical trials
        • Distribution of responsibilities – site vs. monitor
        • Accountability - Site control at receiving IMP
        5 Sep 2025 8:30-15:30
        Day 3
        • Monitoring and collaboration with sites
          • Monitoring in general
          • Pre-study Visit and Initiation Visit
          • Monitoring Visits
          • Close out Visit
        • Risk based quality management
        • Site audits & Inspections
          • Requirement for quality systems
          • Audit and Inspection types
          • Findings


          Practical information

          Related exams

          2 Oct 2025 10:00-13:00
          Go to exam page

          Registration

          Registration deadline
          27 Aug 2025
          Atrium
          Lersø Parkallé 101
          2100 København Ø
          Register
          3 - 5 Sep
          10 Nov 2025 9:00-16:00
          Day 1
          • ICH-GCP
            • Investigator’s role and responsibilities
            • Investigator’s oversight/supervision
            • Sponsor’s role and responsibilities
            • Sponsor’s oversight
            • Danish legislation
          • Introduction to clinical drug development
          • Involved authorities:
            • Danish Medicines Agency (DKMA)
              • DKMA’s role
              • Danish legislation on this topic
              • Approval procedure
            • The independent ethical committee system
              • Overview of the committee system
              • Approval process
              • Subject information and informed consent
          • Group work
            11 Nov 2025 9:00-16:00
            Day 2
            • Clinical trial data (collection)
              • Trial data
              • CRF
              • Source data
            • General Data Protection Regulation (GDPR)
              • Terminology
              • Distribution of responsibilities (Data owner / Data processor)
            • Essential documents
              • Trial Master File
              • Investigator’s Brochure
              • Protocol
              • Subject information and informed consent
              • ID- and Screenings Log
              • Delegation log
              • Contracts
            • Safety reporting
              • Definitions
              • Standards for reporting
              • Areas of responsibilities
            • Group work
            • Handling of investigational medicinal product (IMP) in clinical trials
              • Distribution of responsibilities – site vs. monitor
              • Accountability - Site control at receiving IMP
              12 Nov 2025 9:00-16:00
              Day 3
              • Monitoring and collaboration with sites
                • Monitoring in general
                • Pre-study Visit and Initiation Visit
                • Monitoring Visits
                • Close out Visit
              • Risk based quality management
              • Site audits & Inspections
                • Requirement for quality systems
                • Audit and Inspection types
                • Findings


                Practical information

                Related exams

                4 Dec 2025 10:00-13:00
                Go to exam page

                Registration

                Registration deadline
                3 Nov 2025
                Atrium
                Lersø Parkallé 101
                2100 København Ø
                Register
                10 - 12 Nov
                13 Apr 2026 9:00-17:00
                Day 1
                • ICH-GCP
                  • Investigator’s role and responsibilities
                  • Investigator’s oversight/supervision
                  • Sponsor’s role and responsibilities
                  • Sponsor’s oversight
                  • Danish legislation
                • Introduction to clinical drug development
                • Involved authorities:
                  • Danish Medicines Agency (DKMA)
                    • DKMA’s role
                    • Danish legislation on this topic
                    • Approval procedure
                  • The independent ethical committee system
                    • Overview of the committee system
                    • Approval process
                    • Subject information and informed consent
                • Group work
                  14 Apr 2026 8:30-16:40
                  Day 2
                  • Clinical trial data (collection)
                    • Trial data
                    • CRF
                    • Source data
                  • General Data Protection Regulation (GDPR)
                    • Terminology
                    • Distribution of responsibilities (Data owner / Data processor)
                  • Essential documents
                    • Trial Master File
                    • Investigator’s Brochure
                    • Protocol
                    • Subject information and informed consent
                    • ID- and Screenings Log
                    • Delegation log
                    • Contracts
                  • Safety reporting
                    • Definitions
                    • Standards for reporting
                    • Areas of responsibilities
                  • Group work
                  • Handling of investigational medicinal product (IMP) in clinical trials
                    • Distribution of responsibilities – site vs. monitor
                    • Accountability - Site control at receiving IMP
                    15 Apr 2026 8:30-15:30
                    Day 3
                    • Monitoring and collaboration with sites
                      • Monitoring in general
                      • Pre-study Visit and Initiation Visit
                      • Monitoring Visits
                      • Close out Visit
                    • Risk based quality management
                    • Site audits & Inspections
                      • Requirement for quality systems
                      • Audit and Inspection types
                      • Findings


                      Practical information

                      Related exams

                      12 May 2026 10:00-13:00
                      Go to exam page

                      Registration

                      Registration deadline
                      6 Apr 2026
                      Atrium
                      Lersø Parkallé 101
                      2100 København Ø
                      Register
                      13 - 15 Apr
                      24 Aug 2026 9:00-16:00
                      Day 1
                      • ICH-GCP
                        • Investigator’s role and responsibilities
                        • Investigator’s oversight/supervision
                        • Sponsor’s role and responsibilities
                        • Sponsor’s oversight
                        • Danish legislation
                      • Introduction to clinical drug development
                      • Involved authorities:
                        • Danish Medicines Agency (DKMA)
                          • DKMA’s role
                          • Danish legislation on this topic
                          • Approval procedure
                        • The independent ethical committee system
                          • Overview of the committee system
                          • Approval process
                          • Subject information and informed consent
                      • Group work
                        25 Aug 2026 9:00-16:00
                        Day 2
                        • Clinical trial data (collection)
                          • Trial data
                          • CRF
                          • Source data
                        • General Data Protection Regulation (GDPR)
                          • Terminology
                          • Distribution of responsibilities (Data owner / Data processor)
                        • Essential documents
                          • Trial Master File
                          • Investigator’s Brochure
                          • Protocol
                          • Subject information and informed consent
                          • ID- and Screenings Log
                          • Delegation log
                          • Contracts
                        • Safety reporting
                          • Definitions
                          • Standards for reporting
                          • Areas of responsibilities
                        • Group work
                        • Handling of investigational medicinal product (IMP) in clinical trials
                          • Distribution of responsibilities – site vs. monitor
                          • Accountability - Site control at receiving IMP
                          26 Aug 2026 9:00-16:00
                          Day 3
                          • Monitoring and collaboration with sites
                            • Monitoring in general
                            • Pre-study Visit and Initiation Visit
                            • Monitoring Visits
                            • Close out Visit
                          • Risk based quality management
                          • Site audits & Inspections
                            • Requirement for quality systems
                            • Audit and Inspection types
                            • Findings


                            Practical information

                            Related exams

                            24 Sep 2026 10:00-13:00
                            Go to exam page

                            Registration

                            Registration deadline
                            17 Aug 2026
                            Atrium
                            Lersø Parkallé 101
                            2100 København Ø
                            Register
                            24 - 26 Aug
                            30 Nov 2026 9:00-16:00
                            Day 1
                            • ICH-GCP
                              • Investigator’s role and responsibilities
                              • Investigator’s oversight/supervision
                              • Sponsor’s role and responsibilities
                              • Sponsor’s oversight
                              • Danish legislation
                            • Introduction to clinical drug development
                            • Involved authorities:
                              • Danish Medicines Agency (DKMA)
                                • DKMA’s role
                                • Danish legislation on this topic
                                • Approval procedure
                              • The independent ethical committee system
                                • Overview of the committee system
                                • Approval process
                                • Subject information and informed consent
                            • Group work
                              1 Dec 2026 9:00-16:00
                              Day 2
                              • Clinical trial data (collection)
                                • Trial data
                                • CRF
                                • Source data
                              • General Data Protection Regulation (GDPR)
                                • Terminology
                                • Distribution of responsibilities (Data owner / Data processor)
                              • Essential documents
                                • Trial Master File
                                • Investigator’s Brochure
                                • Protocol
                                • Subject information and informed consent
                                • ID- and Screenings Log
                                • Delegation log
                                • Contracts
                              • Safety reporting
                                • Definitions
                                • Standards for reporting
                                • Areas of responsibilities
                              • Group work
                              • Handling of investigational medicinal product (IMP) in clinical trials
                                • Distribution of responsibilities – site vs. monitor
                                • Accountability - Site control at receiving IMP
                                2 Dec 2026 9:00-16:00
                                Day 3
                                • Monitoring and collaboration with sites
                                  • Monitoring in general
                                  • Pre-study Visit and Initiation Visit
                                  • Monitoring Visits
                                  • Close out Visit
                                • Risk based quality management
                                • Site audits & Inspections
                                  • Requirement for quality systems
                                  • Audit and Inspection types
                                  • Findings


                                  Practical information

                                  Related exams

                                  7 Jan 2027 10:00-13:00
                                  Go to exam page

                                  Registration

                                  Registration deadline
                                  23 Nov 2026
                                  Atrium
                                  Lersø Parkallé 101
                                  2100 København Ø
                                  Register
                                  30 Nov - 2 Dec
                                  Please note: The programme structure may be subject to minor adjustments

                                  Course information

                                  Literature

                                  Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

                                  Please familiarize yourself with the mandatory readings before starting the course.

                                  The mandatory readings are also part of the examination syllabus.

                                  Prerequisites

                                  Experience with contractual relations in clinical trials is an advantage, but not a requirement.

                                  Examination

                                  The exam is held online, usually 4-6 weeks after the course.

                                  You will receive a link with exam questions via your personal Atrium log-in.

                                  In order to participate in the exam, you must have attended the course.

                                  Course leaders

                                  Lene Palfelt
                                  Head of People & Capabilities
                                  Novo Nordisk A/S
                                  Lærke Brygger Madsen
                                  GCP-koordinator, cand.scient.med
                                  Region Nordjylland

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                                  Want to know more or need help?

                                  Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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